Sun Safety Skills for Elementary School Students
1 other identifier
interventional
96
1 country
1
Brief Summary
The overarching goal of this work is to pilot-test a song-based instructional video designed to help elementary school (kindergarten) age children independently apply sunscreen effectively (i.e., covers all needed areas), efficiently (i.e., can be accomplished in 2-3 minutes), consistently (i.e., continues to apply sunscreen routinely before recess both during and after the intervention), without impacting classroom function (i.e., no mess). The video is also designed to encourage use of hats and sunglasses. The outcomes of interest include identification of "gaps" in skills that are consistent for this age group (i.e., commonly miss application to the back of neck), areas of learning refinement (i.e., generalization of skills with different outfits on), and flexibility in terms of adapting practice (i.e., can they do it without the video). The investigators hope that this pilot project will pave the way for broader clinical / educational implementation of this intervention within schools.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 26, 2018
CompletedStudy Start
First participant enrolled
February 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2019
CompletedAugust 13, 2019
August 1, 2019
2 months
October 16, 2018
August 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Teacher Ratings of Kinder Students' Successful/Not Successful Self-Application of Sunscreen.
Change in the proportion of kindergarten students who successfully complete independent self-application of sunscreen within the allotted 2.5 minute time window from baseline (Time 1) to posttreatment (Time 2). Successful completion of the sun screen task (i.e., Kinder Students' self-application of sunscreen within the 2.5 minute window allotted by the intervention) will be determined via direct observation by the classroom teacher. Teachers will be formally trained by the study staff to rate student performance (i.e., successful/not successful) with self-application of sunscreen per a manualized study protocol.
Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)
Secondary Outcomes (4)
Teacher Identified Barriers to Kinder Student Self-Application of Sunscreen
Baseline to Posttreatment (Time 1 - Time 2; each Time is up to 15 minutes and separated by 2 weeks)
Teacher, parent and administrator perceptions of intervention utility.
Posttreatment (Time 2; up to 15 minutes)
Teacher, parent and administrator perceptions of intervention value.
Posttreatment (Time 2; up to 15 minutes)
Student perceptions of intervention likability
Posttreatment (Time 2; up to 15 minutes)
Study Arms (2)
Extended intervention
ACTIVE COMPARATORUpon completion of the two-week baseline period and two-week standard intervention period, the two classrooms assigned to the Extended intervention condition will receive the "I wear sunscreen everyday" song-based video intervention daily for two additional weeks.
Maintenance
NO INTERVENTIONThe two classrooms assigned to the Maintenance condition will continue to receive a two- minute window for sunscreen application, but no "I wear sunscreen everyday" song-based video instruction. Change trajectories from Time 3-Time 4 (two-week follow up) will be compared by follow-up assignment condition and will provide preliminary information about dosing and maintenance effects.
Interventions
All four classes (arms) will be shown (sitting on carpet, not participating) a 2-3 minute song-based video titled "I wear sunscreen everyday" in which they observe elementary age children applying sunscreen in a systematic fashion. Following the viewing, classes will be administered this video guided, song- based intervention while their teacher documents their independent participation using our classroom map data collection sheet.
Eligibility Criteria
You may qualify if:
- General education Kinder students (Sedgwick Elementary School in 2018-2019).
- Child assent and parental consent are required to participate.
You may not qualify if:
- Non-general education status;
- significant medical, mental health and/or behavioral problem
- child refusal of assent or parental refusal of consent;
- known or identified allergy to ingredients in sunscreen;
- moving out of the grade or school during the intervention or follow-up period;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sedgwick Elementary School
Cupertino, California, 95014, United States
Related Publications (1)
Lee GH, Bae GH, Barnes LA, Pol-Rodriguez MM, Ransohoff KJ, Nord KM, Lu Y, Cannell B, Weitlauf JC. The Sunscreen for Kindergarteners (SKIN) Study trial protocol. Contemp Clin Trials. 2021 Aug;107:106480. doi: 10.1016/j.cct.2021.106480. Epub 2021 Jun 11.
PMID: 34126263DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Nord, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
October 16, 2018
First Posted
November 26, 2018
Study Start
February 25, 2019
Primary Completion
April 11, 2019
Study Completion
May 23, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share